HIGH-VOLUME · FEMALE-LED
sulfasalazine Side Effects
sulfasalazine (also sold as Azulfidine) is HIGH-VOLUME in this FAERS book #96 of 524 by FAERS report count. Signature opener: FEMALE-LED - 77% of sex-coded reports are female (52,098 F / 15,843 M).
Data updated 2026-05-15
- 76,270
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
sulfasalazine reporting skew - 77% of sex-coded reports are female (52,098 F / 15,843 M). Volume band HIGH-VOLUME #96 of 524 by FAERS report count; caseload CASELOAD.
High-report extract for sulfasalazine (Azulfidine): 76,270 FAERS rows (2003-2025). Top named reactions: RHEUMATOID ARTHRITIS, PAIN, ARTHRALGIA. Outcome stamps DEATH-HEAVY · HOSP-MID · FEMALE-LED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
RHEUMATOID ARTHRITIS leads 19,190 of 76,270 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (77% of sex-coded rows)
Age peak 45-64 (20,646 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (6,629 reports, 8.7%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 2,082 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,074 |
| TYPE 2 DIABETES MELLITUS | 2,028 |
| JOINT SWELLING | 1,999 |
| SYNOVITIS | 1,970 |
| RASH | 1,961 |
| GLOSSODYNIA | 1,958 |
| WOUND | 1,945 |
| PSORIATIC ARTHROPATHY | 1,939 |
| INFUSION RELATED REACTION | 1,933 |
| PAIN | 1,910 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,904 |
| HAND DEFORMITY | 1,874 |
| HYPOAESTHESIA | 1,874 |
| FATIGUE | 1,871 |
| FIBROMYALGIA | 1,869 |
| SWELLING | 1,847 |
| HEPATIC ENZYME INCREASED | 1,840 |
| DUODENAL ULCER PERFORATION | 1,834 |
Reactions in Hospitalization Reports
Hospitalization mid-share (20,613, 27.0%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| RHEUMATOID ARTHRITIS | 5,015 |
| PAIN | 4,516 |
| ARTHRALGIA | 4,487 |
| JOINT SWELLING | 4,240 |
| FATIGUE | 4,179 |
| RASH | 3,909 |
| CONDITION AGGRAVATED | 3,681 |
| SYNOVITIS | 3,637 |
| DRUG HYPERSENSITIVITY | 3,524 |
| ARTHROPATHY | 3,515 |
| NAUSEA | 3,311 |
| INFUSION RELATED REACTION | 3,271 |
| HYPERSENSITIVITY | 3,192 |
| PERIPHERAL SWELLING | 3,191 |
| ABDOMINAL DISCOMFORT | 3,184 |
| VOMITING | 3,105 |
| DIARRHOEA | 3,103 |
How to read sulfasalazine FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 76,270 voluntary reports linked to sulfasalazine (Azulfidine), 2003-2025. Death is listed on 6,629 (8.7%). Hospitalization appears on 20,613 (27.0%). Top co-reported indication: Rheumatoid Arthritis.
CASELOAD books overweight common drugs and loud reporting cultures; FEMALE-LED is the page opener, not a per-patient risk.
Read with sulfasalazine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 75,912 FAERS cases (Δ 358 lighter vs sulfasalazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 78,359 FAERS cases (Δ 2,089 heavier vs sulfasalazine); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 73,430 FAERS cases (Δ 2,840 lighter vs sulfasalazine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(total_reports) peer at 72,798 FAERS cases (Δ 3,472 lighter vs sulfasalazine); DEATH-MARKED · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 53.4 pp vs sulfasalazine's DEATH-HEAVY): CASELOAD · HOSP-MID.
sulfasalazine stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.